Creon (pancrelipase) Delayed-Release Capsules Improves Digestive Outcomes In Adults With Chronic Pancreatitis
- NEW DATA SUPPORT SAFE AND EFFECTIVE USE OF CREON TO TREAT EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS OR PANCREATIC SURGERY -
MARIETTA, Ga., Oct. 26 /PRNewswire/ -- Solvay Pharmaceuticals,
Inc. announced today that new data demonstrate that CREON®
(pancrelipase) Delayed-Release Capsules significantly improves a
key measure of fat absorption in adults with exocrine pancreatic
insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatic
surgery. EPI is a condition resulting from a deficiency in the
production and/or secretion of pancreatic enzymes that are
necessary to digest nutrients in food and, if untreated, can lead
to diarrhea, weight loss and ultimately malnutrition.
Findings from this Phase III study, which have been submitted to
the FDA, were presented at the American College of Gastroenterology
Annual Scientific Meeting in San Diego, California, on Sunday,
October 25th, by Dr. David C. Whitcomb, in a poster titled
"Efficacy and safety of pancrelipase delayed-release capsules
(CREON®) in patients with pancreatic insufficiency due to
chronic pancreatitis or pancreatic surgery," poster number P101.
Among FDA-approved pancreatic enzyme replacement therapies (PERTs),
this study provides important new data to evaluate PERT dosing
specifically in patients with EPI due to CP or pancreatic
surgery.
"The maldigestion associated with EPI due to chronic
pancreatitis and pancreatic surgeries can result in malnutrition as
well as debilitating pain and GI symptoms that negatively impact
quality of life for these patients," said David C. Whitcomb, M.D.,
Ph.D., University of Pittsburgh Medical Center. "These data support
the use of PERT to improve the absorption of fat in patients
receiving diets of at least 100 g of fat per day, which serves as
an important demonstration to clinicians that EPI can be
effectively treated without restricting patients' diets to be very
low in fat."
According to the study results, adults with CP or who have
undergone pancreatic surgery, who took CREON®, had an improved
coefficient of fat absorption (CFA) as compared to the placebo
group. CFA is calculated based on measures of fat ingestion and fat
excretion; assessing the CFA of a patient is another way to measure
the absorption of fat as a percentage of fat intake in patients
being tested for EPI. The primary efficacy endpoint was the change
in CFA from baseline to the end of the double-blind treatment
period. The CFA improved by 32.1% in the CREON® group compared
to 8.8% in the placebo group, representing a statistically
significant difference between CREON® and placebo
(P<0.0001).
"These data add to the growing body of evidence supporting the
efficacy and safety profile of CREON® across multiple
conditions while also providing clarity around the appropriate
dosing of pancreatic enzyme replacement therapy in these patients,"
said Elizabeth M. Mutisya, M.D., Vice President of U.S. Medical
Affairs and Chief Medical Officer at Solvay Pharmaceuticals, Inc.
"These CREON® study results are encouraging as dosing of
pancreatic enzymes for patients with EPI due to CP or pancreatic
surgery has not previously been well defined."
Study Details
The double-blind, randomized, placebo-controlled, two-arm,
parallel-group study conducted in the United States, Eastern and
Central Europe, examined the efficacy and safety of CREON®
12,000-lipase unit capsules in 52 adults aged 18 years or older
with EPI due to CP or pancreatic surgery. Patients were randomized
to receive CREON® 12,000-lipase unit capsules at a dose of
72,000 lipase units per main meal and 36,000 lipase units per snack
or matching placebo. EPI was confirmed in all subjects through
direct pancreatic function testing such as, secretin tests or fecal
elastase (< 100 micrograms/g), 72-hour fecal fat determination
(> 15 g/day) or pancreatectomy more than 180 days prior to study
enrollment.
Upon analysis of the primary efficacy results, the mean CFA
increased by 32.1% in the CREON® group and 8.8% in the placebo
group, with a statistically significant difference between
CREON® and placebo (p < 0.0001). Thus, the study met its
primary objective, showing a superior efficacy of CREON® over
placebo on the key measure of CFA. Overall symptoms of maldigestion
improved from baseline to a greater extent in CREON®-treated
patients compared with placebo, with significantly greater
improvements in stool characteristics, flatulence, and stool
consistency. CREON® was well-tolerated and had a similar
adverse event profile to that of placebo. A low number of
treatment-emergent adverse events were reported; primarily
gastrointestinal events and metabolic/nutritional disorders.
About Exocrine Pancreatic Insufficiency and Pancreatic Enzyme
Replacement Therapy
Exocrine pancreatic insufficiency (EPI) is a condition resulting
from a deficiency in the production and/or secretion of pancreatic
enzymes that are necessary to digest nutrients in food. The safety
and efficacy of prior formulations of pancrelipase in pediatric
patients with EPI due to CF have been described in the medical
literature. Prior formulations of pancrelipase have also
demonstrated clinical efficacy in those patients through years of
clinical experience. PERTs work in patients with EPI by delivering
pancreatic enzymes to the small intestine to help break down fats,
proteins and carbohydrates in food, thereby acting as a replacement
for digestive enzymes physiologically secreted by the pancreas. EPI
can occur as a complication of a variety of diseases or conditions,
including CF, pancreatic cancer, gastrointestinal surgery and
chronic pancreatitis. Statistics show that more than 80% of CF
patients have EPI, which usually develops during the first year of
life.
The original products in the pancreatic enzyme drug class
pre-date modern FDA regulatory requirements. Over the past two
decades, products in this class have been allowed to be marketed as
prescription drugs without formal NDA approval. In 2004, the FDA
required manufacturers to submit New Drug Applications (NDAs) for
all pancreatic enzyme replacement therapies in order to remain on
the market. By April 2010, all pancreatic enzyme replacement
therapies are required to have approved NDAs and must be
manufactured under the new guidelines.
Important Safety Information
Warnings and precautions include fibrosing colonopathy, a rare,
serious adverse reaction that has been described in association
with high-dose use of pancreatic enzyme replacement therapy in the
treatment of cystic fibrosis patients. Caution should be exercised
when doses of CREON® exceed 2,500 lipase units/kg of body
weight per meal (or greater than 10,000 lipase units/kg of body
weight per day). Care should be taken to ensure that CREON® is
not chewed or retained in the mouth to avoid irritation of oral
mucosa. Caution should be exercised when prescribing CREON® to
patients with gout, renal impairment, or hyperuricemia. There is
theoretical risk of viral transmission with all pancreatic enzyme
products, including CREON®. Caution should be exercised when
administering pancrelipase to a patient with a known allergy to
proteins of porcine origin.
In the clinical study used to demonstrate the efficacy and
safety of FDA-approved CREON®, the incidence of adverse events
(regardless of causality) was higher during placebo treatment (71%)
than during CREON® treatment (50%). Treatment-emergent adverse
events occurring in at least two patients (greater than or equal to
6%) receiving CREON® or placebo were abdominal pain, abdominal
pain upper, abnormal feces, cough, dizziness, flatulence, headache,
and weight decreased.
CREON® has been approved with a Risk Evaluation and
Mitigation Strategy (REMS) to ensure that the benefits of the drug
outweigh its risks. As part of the REMS, a Medication Guide with
important dosing and safety information applicable to this class of
products, including CREON®, is provided for patients and
caregivers, with an emphasis on understanding the risk of fibrosing
colonopathy as well as the importance of not over- or under-dosing.
The FDA requires that the Medication Guide be handed out with every
prescription for the drug dispensed.
For full safety and Prescribing Information about the
FDA-approved formulation of CREON®, visit www.CREON.com.
Solvay Pharmaceuticals, Inc., of Marietta, Georgia, is the U.S.
subsidiary of Solvay Pharmaceuticals. For more information, visit
www.solvaypharmaceuticals-us.com.
Solvay Pharmaceuticals is a research driven group of companies
that constitutes the global pharmaceutical business of the Solvay
Group. These companies seek to fulfill carefully selected, unmet
medical needs in the therapeutic areas of neuroscience,
cardiometabolic, influenza vaccines, gastroenterology and men's and
women's health. Its 2008 sales were EUR 2.7 billion and it employs
more than 9,000 people worldwide. For more information, visit
www.solvaypharmaceuticals.com.
Solvay is an international Chemicals and Pharmaceuticals Group
with headquarters in Brussels. It employs some 28,300 people in 50
countries. In 2008, its sales amounted to EUR 9.5 billion generated
by its three activity sectors: Chemicals, Plastics and
Pharmaceuticals. Solvay (NYSE-Euronext: SOLB.BE - Bloomberg:
SOLB.BB - Reuters: SOLBt.BR) is listed on NYSE-Euronext at
Brussels. Details are available at www.solvay.com.
CONTACTS: Jessica Riley Aaron Estrada Solvay Pharmaceuticals, Inc. Ruder Finn (770) 578-5637 (212) 715-1568 jessica.riley@solvay.com estradaa@ruderfinn.com
Source: Solvay Pharmaceuticals, Inc.
CONTACT: Jessica Riley, Solvay Pharmaceuticals, Inc.,
+1-770-578-5637,
jessica.riley@solvay.com;
Aaron Estrada, Ruder Finn, +1-212-715-1568,
estradaa@ruderfinn.com
Web Site: http://www.solvaypharmaceuticals.com/
http://www.solvaypharmaceuticals-us.com/
